Portable Nebulizer

K170916 · Microbase Technology Corporation · CAF · Nov 28, 2017 · Anesthesiology

Device Facts

• Record ID: K170916
• Device Name: Portable Nebulizer
• Applicant: Microbase Technology Corporation
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

Device Story

Handheld, battery-powered vibrating mesh nebulizer; uses piezoelectric ceramic actuator (PZT) to vibrate a polymer mesh with apertures; breaks surface tension of liquid medication to generate aerosol. Operated by patient or caregiver in home, hospital, school, or long-term care settings. User interface includes ON/OFF button and LED indicators (green for normal, orange for malfunction). Device automatically shuts off after 30 minutes. Healthcare providers prescribe medication for use with the device. Benefits include portable, efficient delivery of aerosolized medication for respiratory conditions.

Clinical Evidence

Bench testing only. Comparative aerosol characterization (particle size distribution, MMAD, GSD, total dose, respirable dose) performed against predicate using cascade impactors at adult (28 lpm) and pediatric (12 lpm) flow rates. Biocompatibility testing per ISO 10993-1, electrical safety/EMC testing (IEC 60601-1, 60601-1-2, 60601-1-11), and cleaning/disinfection validation were conducted.

Technological Characteristics

Vibrating mesh technology; piezoelectric ceramic actuator (PZT); polymer mesh. Power: 2x AA alkaline batteries. Dimensions: 77 x 41 x 73 mm. Weight: 74g. Operating frequency: ~117 kHz. Power consumption: <1.5 W. Biocompatible materials per ISO 10993-1. Standards: ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11.

Indications for Use

Indicated for pediatric (5 years+) and adult patients requiring aerosolized liquid medication inhalation. No contraindications.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Omron NE-U22 (K062263)

Reference Devices

• Besmed (K150591)

Submission Summary (Full Text)

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November 28, 2017

MicroBase Technology Corporation % Paul Dryden Consultant MicroBase Technology Corporation c/o ProMedic, LLC. 24301 Woodsage Dr. Bonita Springs, Florida 34134

Re: K170916

Trade/Device Name: Portable Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: October 19, 2017 Received: October 23, 2017

Dear Paul Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tara A. Ryan-S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170916

Device Name

Portable Nebulizer

Indications for Use (Describe)

The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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MicroBase Technology Corporation No. 756, Jiadong Road Bade District, Taoyuan City 33464, Taiwan

| Official Contact: | Molly Hsieh<br>General Manager<br>Tel - 011-886-3-376-7555<br>Fax - 011-886-3-376-7557 |
|----------------------------|----------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Portable Nebulizer |
| Common/Usual Name: | Nebulizer (Direct Patient Interface |
| Classification Name: | Nebulizer (Direct Patient Interface<br>Product Classification – CAF<br>21 CFR 868.5630<br>Class II |
| Predicate Devices: | K062263 - Omron NE-U22 |

## Device Description:

The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.

#### Components

The Medication Cup contains the nebulizing module where aerosol will be generated. Prescribed medication is placed in the Cup, nebulized and inhaled via the integral mouthpiece.

The Medication Cup is single patient, multi-use. Cleaning is performed after each use by rinsing with distilled water and disinfected via immersion in boiled water for 10 minutes. The performance met its specification criteria of 90 days.

The cup medication capacity is 6 ml.

The Main Unit contains the 2 "AA" batteries and firmware to control the vibrating mesh module in the Medication Cup.

Portable Nebulizer aerosolizes upon turning on by pressing the ON/OFF button and turns off by pressing again or automatically after treatment completion in 30 minutes. To monitor nebulization status and device operating condition, there are different LED colors shown. Normal working condition is indicated by a green while an orange color signifies a malfunction.

There is one model of the subject device.

#### Indications for Use:

The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liguid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

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#### 510(k) Summary Page 2 of 7 November 27, 2017

## Principle of Operation / Technology

The Portable Nebulizer operates by electrically activating piezoelectric ceramic actuator (PZT) which then transduces the vibration generated to the adjacent supporting plate and polymer mesh bearing numerous apertures. The vibration actively pushes out the liquid medication by physically breaking surface tension of the solution through mesh holes thereby achieving final nebulization. Aerosol generation can subsequently be modulated the vibration frequency that is controlled by the firmware stored within Main Unit to maintain a frequency of approximate 117 kHz, nebulization rate of > 0.25 ml/min and a power consumption of <1.5 W.

| Features | Proposed Portable Nebulizer |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. |
| Environment of Use | The device may be used with pediatric (5 years old or greater), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities. |
| Patient Population | |
| Contraindications | None |
| Vibrating mesh technology | Yes |
| Software driven | Yes - firmware |
| Patient Interface | Mouthpiece |
| Nebulizer components cleanable | Yes – Medication Cup and mouthpiece |
| Operating conditions | 10°C to 40°C 30% to 85% RH |
| Storage conditions | -20°C to 70°C, 20% to 75% RH |
| Power Source | DC – 2 – AA Alkaline batteries |

## Table 1 - Performance Specifications

## Comparison to Predicate

Tables 2 provides a comparison of the proposed device to the predicate.

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# 510(k) Summary
Page 3 of 7 November 27, 2017

| Features | Predicate<br>Omron NE-U22<br>K062263 | Proposed<br>Portable Nebulizer |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Omron NE-U22 is an ultrasonic<br>(vibrating mesh) nebulizer system designed<br>to aerosolize liquid medications for<br>inhalation by the patient. | The Portable Nebulizer is a vibrating mesh<br>nebulizer system designed to aerosolize<br>liquid medications for inhalation by the<br>patient. |
| Patient Population | The device may be used with pediatric and<br>adult patients | The device may be used with pediatric (5<br>years and older), defined by the prescribed<br>medication, and adult patients |
| Environment of Use | in the home, hospital, and sub-acute care<br>settings.. | in hospital/institutional settings, home care<br>use, schools, and long term care facilities. |
| Contraindications | It is not intended for use with<br>Pentamidine. | None |
| Principle of Operation | Vibrating mesh | Vibrating mesh |
| Aerosolization | Continuous during inhalation and<br>exhalation | Continuous during inhalation and<br>exhalation |
| Compressed gas source | None needed | None needed |
| Reservoir volume | 7 ml | 6 ml |
| Nebulization rate | 0.25 ml/min to 0.9 ml/min | ≥ 0.25 ml/min |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Nebulizer components<br>cleanable | Yes | Yes |
| Software driven | No | Yes |
| Power source | 2- “AA” Battery | 2- “AA” battery |
| Power consumption | 1.5 W | < 1.5 W |
| Weight | 97 gm w/o batteries | 74 gm w/o batteries |
| Dimensions (mm) | 51 x 38 x 104 | 77 x 41 x 73 |
| Operating Conditions | 0 to 45°C / 30-85% RH | 10 to 40°C / 30-85% RH |
| Storage Conditions | -25 to +70°C / 10-90% RH | -20 to +70°C / 20-75% RH |
| User interface | On/Off switch<br>LED indicators | On/Off switch<br>LED indicators |
| Standards met | ES60601-1<br>IEC 60601-1-2 | ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-11 |
| Materials per ISO<br>10993-1 | External Communicating<br>(Indirect gas pathway)<br>Tissue / Bone / Dentin communicating<br>Duration of Use - permanent (> 30 days)<br>And<br>Surface Contact<br>Mucosal membrane<br>Duration of Use - permanent (> 30 days) | External Communicating<br>(Indirect gas pathway)<br>Tissue / Bone / Dentin communicating<br>Duration of Use - permanent (> 30 days)<br>And<br>Surface Contact<br>Mucosal membrane<br>Duration of Use - permanent (> 30 days) |
| MMAD | MMAD, GSD, Total Respirable Dose, and<br>the predicate. | Total Dose were substantially equivalent to |
| GSD | | |
| Total Respirable Dose | | |
| Total Dose | | |
| Features | Predicate<br>Omron NE-U22<br>K062263 | Proposed<br>Portable Nebulizer |
| Software | | |
| Level of Concern | Moderate | Moderate |
| Device Specific | Yes | Yes |
| Dependent on external<br>devices | No | No |
| Signals | LED and tone sounds | LED and tone sounds |

# Table 2 – Comparison of Proposed vs. Predicate Device

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#### 510(k) Summary Page 4 of 7 November 27, 2017

## Substantial Equivalence Discussion

The Portable Nebulizer is viewed as substantially equivalent to the predicate device because:

Indications for Use – The proposed indications for use are to aerosolize commonly prescribed medications.

Discussion - The indications for use are identical for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

The exclusion of the reference to pentamidine is no longer included in nebulizer indications for use, K150591, and has been removed.

Patient Population - The patient population of adult and pediatric (defined by the prescribed medication) patients that is consistent with the indications for the aerosol medication. This is similar to the predicate - K062263 - Omron NE-U22 nebulizer.

Discussion - The patient population is similar for the proposed device and the predicate -K062263 - Omron NE-U22 nebulizer. The predicate does not describe the pediatric population, however other reference nebulizers have defined the patient population as "pediatric (2 years and older) and / or as "defined by the prescribed medication" - K150591 - Besmed. Thus the differences in the description of the patient population compared to the predicate can be found to be substantially equivalent.

Environment of Use – The proposed environments of use are common and usual for handheld nebulizers, namely Hospital/institutional settings, home care use, schools and long term care facilities.

Discussion - The environment of use is identical for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Technology - The design as a vibrating mesh nebulizer which is the identical principle of operation.

Discussion - The technology is identical for the proposed device as compared to the predicate -K062263 – Omron NE-U22 nebulizer.

## Summary of Non-Clinical Performance Testing

We performed a number of non-clinical tests to demonstrate that the Portable Nebulizer is equivalent to the predicate K062263 - Omron NE-U22 nebulizer.

- Shelf-life, Useful-life, and Durability Testing
- Simulated Life Cycle testing ●
- Cleaning ●
- Electrical Safety, EMC, EMC ●

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#### 510(k) Summary Page 5 of 7 November 27, 2017

- Particle Characterization per Cascade Impactor
- . Intra- and Inter- Sample Variability

## Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. Testing established that, with respect to electrical safety, the device meets the applicable requirements of: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2007; (3) IEC 60601-1-11:2012.

## Software Verification and Validation Testing

Verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA's Guidance 337, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is of a "moderate" level of concern, since a failure or latent flaw in the software could lead to a delay in delivery of appropriate medical care.

## Biocompatibility

The materials in patient / drug contact are characterized as:

- External Communicating (Indirect gas pathway)
- Tissue / Bone / Dentin communicating
- . Duration of Use - permanent (> 30 days)

And

- Surface Contact ●
- Mucosal membrane
- Duration of Use permanent (> 30 days) .

Discussion - We performed ISO 10993-1 tests to support biocompatibility. They included:

- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Sub-chronic Systemic toxicity ●
- Acute Systemic Toxicity ●
- Leachable and Extractables with Risk Based Assessment .
- Gas Emission VOC plus Inorganic compounds - CO, CO2, and Ozone
- PM25 ●

Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.

## Cleaning and Disinfection Validation

Microbiological efficiency control tests were conducted in order to validate the nebulizer cleaning and disinfection methods in the IFU. Testing involved validation of: (1) a manual cleaning method and a thermal disinfection method. All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.

## Particle Characterization

Comparative aerosol characterization (particle size distribution) performed between the subject and predicate device. The following tables summarize the results, in all the results very similar compared to that of the predicate.

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#### 510(k) Summary Page 6 of 7 November 27, 2017

| Features | Predicate<br>Omron NE-U22<br>K062263 | | Proposed<br>Portable Nebulizer | |
|----------------------------------------------------------------------|--------------------------------------|-------------|--------------------------------|----------------|
| Particle Characterization per Cascade Impactor @ 28 lpm – Adult Flow | | | | |
| Total Dose (ug) | Albuterol – | 1232 – 1362 | Albuterol – | 1719 – 2082* |
| | Ipratropium – | 240 – 295 | Ipratropium – | 347 – 403* |
| | Cromolyn – | 7648 – 9249 | Cromolyn – | 13372 – 14329* |
| Particle size (MMAD)<br>(Microns) | Albuterol – | 2.5 – 3.6 | Albuterol – | 1.9 – 2.8* |
| | Ipratropium – | 1.8 – 4.2 | Ipratropium – | 2.0 – 2.7 |
| | Cromolyn – | 1.9 – 3.0 | Cromolyn – | 2.1 – 2.8 |
| Geometric Std. Dev.<br>(GSD) | Albuterol – | 2.1 – 3.0 | Albuterol – | 1.9 – 2.6 |
| | Ipratropium – | 2.4 – 3.7 | Ipratropium – | 2.1 – 2.6* |
| | Cromolyn – | 2.3 – 3.0 | Cromolyn – | 2.3 – 2.8 |
| Total Respirable Dose<br>(0.5-5 microns) | Albuterol – | 659 – 965 | Albuterol – | 1274 – 1487* |
| | Ipratropium – | 97 – 201 | Ipratropium – | 237 – 275* |
| | Cromolyn – | 4337 – 6601 | Cromolyn – | 8645 – 9954* |
| Coarse Particle Dose<br>(>4.7 micron) | Albuterol – | 373 – 631 | Albuterol – | 279 – 726 |
| | Ipratropium – | 82 – 145 | Ipratropium – | 85 – 138 |
| | Cromolyn – | 2312 – 3206 | Cromolyn – | 3723 – 4676* |
| Fine Particle Dose<br>(<4.7 micron) | Albuterol – | 657 – 934 | Albuterol – | 1290 – 1506* |
| | Ipratropium – | 95 – 213 | Ipratropium – | 241 – 286* |
| | Cromolyn – | 4607 – 6771 | Cromolyn – | 8995 – 10307* |
| Ultra-fine Particle<br>Dose<br>(< 1.0 micron) | Albuterol – | 97 – 154 | Albuterol – | 215 – 354* |
| | Ipratropium – | 21 – 67 | Ipratropium – | 49 – 68 |
| | Cromolyn – | 1211 – 1574 | Cromolyn – | 1524 – 2736* |
| Confidence level of<br>testing | 95% confidence level | | 95% confidence level | |

# Table 3 – Comparative Aerosol Performance – Adult Flow Rate – 28 Ipm

Overall the results support substantial equivalence argument.

# Table 4 – Comparative Aerosol Performance – Pediatric Flow Rate – 12 Ipm

| Features | Predicate<br>Omron NE-U22<br>K062263 | Proposed<br>Portable Nebulizer |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Particle Characterization per Cascade Impactor @ 12 lpm – Pediatric Flow | | |
| Total Dose (ug) | Albuterol – 1967-2379<br>Ipratropium – 411-451<br>Cromolyn – 16066-17807 | Albuterol – 2159-2592<br>Ipratropium – 429-505<br>Cromolyn – 17733-18426 |
| Particle size (MMAD)<br>(Microns) | Albuterol – 5.09-6.91<br>Ipratropium – 6.50 -6.97<br>Cromolyn – 6.60-6.86 | Albuterol – 3.31-4.95*<br>Ipratropium – 4.34-5.72*<br>Cromolyn – 3.68-5.38* |
| Geometric Std. Dev.<br>(GSD) | Albuterol – 2.25-2.85<br>Ipratropium – 2.76-3.09<br>Cromolyn – 2.71-3.52 | Albuterol – 2.03-2.72<br>Ipratropium – 2.39-3.50<br>Cromolyn – 2.56-2.89 |
| Total Respirable Dose<br>(0.5-5 microns) | Albuterol – 711-942<br>Ipratropium - 140-160<br>Cromolyn - 5559-6501 | Albuterol – 1071-1596*<br>Ipratropium - 198-219*<br>Cromolyn - 7925-10601* |
| Coarse Particle Dose<br>(>4.7 micron) | Albuterol – 1121-1626<br>Ipratropium – 273-302<br>Cromolyn - 10302-11415 | Albuterol – 913-1214<br>Ipratropium - 213-291<br>Cromolyn - 7240-10277 |

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#### 510(k) Summary Page 7 of 7 November 27, 2017

| Features | Predicate<br>Omron NE-U22<br>K062263 | | Proposed<br>Portable Nebulizer | |
|-----------------------------------------------|--------------------------------------|-----------|--------------------------------|-------------|
| Fine Particle Dose<br>(<4.7 micron) | Albuterol - | 743-856 | Albuterol - | 1026-1597* |
| | Ipratropium - | 134-153 | Ipratropium - | 212-218* |
| | Cromolyn - | 5737-6418 | Cromolyn - | 8135-10507* |
| Ultra-fine Particle<br>Dose<br>(< 1.0 micron) | Albuterol - | 65-80 | Albuterol - | 31-220 |
| | Ipratropium - | 14-17 | Ipratropium - | 14-44 |
| | Cromolyn - | 808-969 | Cromolyn - | 887-1904 |
| Confidence level of<br>testing | 95% confidence level | | 95% confidence level | |

Overall the results support substantial equivalence argument.

Particle size characterization (MMAD) was verified after two years of real-time aging using both cascade impactor technique and laser light scattering technique.

# Substantial Equivalence Conclusion

As detailed, the indications for use, patient population, environment of use, technology or principle of operation and performance are substantially equivalent.

The differences between the proposed Portable Nebulizer and the predicate – K062263 – Omron Model NE-U22 based upon the comparative performance testing we can conclude that the proposed device can be determined to be substantially equivalent to the predicate.